Chemistry, Manufacturing & Controls (API and Drug Product)
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NGT BioPharma Consultants’ Chemistry, Manufacturing & Controls (CMC) services support both small molecules and biologics (Mabs, duobodies, proteins, cell therapy, gene therapy, and other new modalities), API, analytical, and drug product disciplines while recognizing that their relevance varies depending on a project’s stage of development.
Our broad capabilities and expertise can be applied as early as late-stage discovery and continue through preclinical and clinical drug development, registration, commercialization, and life-cycle management. Our CMC consultants also work seamlessly with other drug development functional areas, such as Nonclinical, Clinical, Quality/ Compliance, and Regulatory. NGT BioPharma Consultants’ capabilities in CMC (API and Drug Product) include, but are not limited to the services highlighted below:
EARLY-STAGE DEVELOPMENT
- Pharmaceutical “developability” assessment and optimization of lead compounds
- Physico-chemical characterization of new chemical entities (NCEs)
- Pharmaceutical development strategy (API, analytical, drug product, clinical supply)
- Fit-for-purpose API synthesis and formulation (oral, iv, fixed-dose combinations) development
- Analytical methods development
- Ensure Quality Target Product Profile achieves desired Target Product Profile
- CMC information for IND/CTA and European IMPD applications
- Select and/or qualify CDMO’s and CRO’s; coordinate and provide oversight
LATE-STAGE DEVELOPMENT
- Pharmaceutical development strategy for pivotal clinical studies and commercial manufacturing
- Select and/or qualify CDMO’s and CRO’s; coordinate and provide oversight
- Clinical supplies for pivotal studies, including strategies for using comparator drugs
- Commercial API synthesis, formulation, and process development
- Analytical control strategies for commercial product, storage conditions, and shelf life
- Scale-up and building of commercial supply chain; achieving launch readiness
- CMC information for NDA, BLA, and MAA submissions, and other regulatory submissions worldwide
- Strategies for life-cycle management: cost optimizations; supporting new indications, new dosage forms and formulations
PRECLINICAL AND CLINICAL DRUG DEVELOPMENT
- Assess IND-enabling studies for submission readiness
- Establish a local or global regulatory strategies, including plans for leveraging expedited pathways and special programs
- Optimize, create and submit meeting requests, meeting packages and briefing books
- Provide IND and CTA maintenance (initial submissions, amendments, annual and periodic reports and closure
REGISTRATION
- Prepare companies for Pre-NDA meetings and scientific advice
- Create and manage Emergency Use Authorizations submissions
- Provide NDA/BLA/MAA dossier authoring and regulatory project management
- Priority review requests
- Managing responses to health authority questions
ADDITIONAL SERVICES
- U.S. Agent for non-U.S. entities
- Regulatory due diligence, gap analyses and risk management
- Rare Pediatric Disease Designations
- Special Protocol Assessments
- Expedited program requests (Breakthrough, Fast Track, Priority Review, Accelerated Approval)
- Orphan Drug Designations
- Regulatory strategy refinement and optimization
EARLY-STAGE DEVELOPMENT
- Pharmaceutical “developability” assessment and optimization of lead compounds
- Physico-chemical characterization of new chemical entities (NCEs)
- Pharmaceutical development strategy (API, analytical, drug product, clinical supply)
- Fit-for-purpose API synthesis and formulation (oral, iv, fixed-dose combinations) development
- Analytical methods development
- Ensure Quality Target Product Profile achieves desired Target Product Profile
- CMC information for IND/CTA and European IMPD applications
- Select and/or qualify CDMO’s and CRO’s; coordinate and provide oversight
LATE-STAGE DEVELOPMENT
- Pharmaceutical development strategy for pivotal clinical studies and commercial manufacturing
- Select and/or qualify CDMO’s and CRO’s; coordinate and provide oversight
- Clinical supplies for pivotal studies, including strategies for using comparator drugs
- Commercial API synthesis, formulation, and process development
- Analytical control strategies for commercial product, storage conditions, and shelf life
- Scale-up and building of commercial supply chain; achieving launch readiness
- CMC information for NDA, BLA, and MAA submissions, and other regulatory submissions worldwide
- Strategies for life-cycle management: cost optimizations; supporting new indications, new dosage forms and formulations
Although NGT is neither a laboratory or manufacturing services provider, we can serve as your single point of contact to our network of reputable CRO’s and CDMO’s.
Working with Big Pharma Globally
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Get in touch
For more information pertaining to Regulatory Strategy & Application Preparation please contact Roger or Rachel on the details below. Alternatively please fill in the form and our team in this field will get back to you.
New Enquiry
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